Clinart MENA provides full project management support for global Phase I through IV trials in different therapeutic areas.

Services

Project Management

The project manager is a critical part of a study’s success. We assign experienced project managers with proven expertise in clinical and late stage research. The project manager is responsible for the technical and administrative aspects of the study as defined by the client.

Study feasibility and site selection

Clinart’s Feasibility group provides comprehensive study feasibility assessments for clinical trials and drug development programs worldwide.


We provide support in

  • Identifying protocol design concerns/constraints
  • Determining availability of appropriate patient population
  • Understanding potential investigators’ overall interest in the trial design
  • Targeting optimal regions or countries
  • Determining disease prevalence/incidence
  • Understanding regional standards-of-care
  • Identifying investigators who best fit study needs

Study startup and regulatory submissions

Clinart's project start-up services include

  • Recruiting investigational sites
  • Supporting in regulatory authority submissions
  • Coordinating ethics committee approvals
  • Collecting and reviewing initial essential documents
  • Closing investigator contracts (clinical trial agreements)

Site monitoring activities

Our skilled and well-trained clinical research associates (CRAs) ensure the highest quality review of data and effective interaction with study sites.

 

Our CRAs conduct on-site monitoring visits throughout the study to

  • Oversee data collection
  • Review source documentation and case report forms
  • Ensure regulatory compliance
  • Resolve data queries
  • Conduct interim analyses as requested by clients

 

Clinart is dedicated to employing and retaining well-qualified CRAs who

  • Have demonstrated site monitoring proficiency before being allocated to a study
  • Are typically dedicated to one protocol at a time to maintain quality

Study drug logistics(import)

Clinart provides support in

  • Study drug import License & Logistics
  • Sample export licenses & Logistics

 

Clinart is dedicated to employing and retaining well-qualified CRAs who

  • Have demonstrated site monitoring proficiency before being allocated to a study
  • Are typically dedicated to one protocol at a time to maintain quality

 

 

Clinical Operations Record

Local Expertise at Global Standards

 

Early Phase Experience

37

Protocols Implemented

1,941

Patients Recruited

109

Sites since 2003

 

Late Phase Experience  

 

62

Protocols Implemented

 

21,191

Patients Recruited

 

747

Sites since 2003

 

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